Background:Key responsibilities* Continuous enhancement of the Quality Management Systems (ISO 13485, CMDCAS, FDA / cGMP, 21 CFR Part 820 and IVD directive 98/79/ECC as well as the retention of the certification status)* Development and maintenance of the functional competence in line with international requirements for the state of the art Quality Management System for manufacturing medical devices* Internal audit program, customer audits, inspections by certification agencies and other Bodies* Adherence to the cost centre budget* Maintain the training matrices* Represent Quality Management on site

A suitable candidate for this role might be degree qualified in the Life Sciences (chemistry, biochemistry, biology) with practical experience in Quality Management for Medical Devices (ISO 13485 and ISO 9001), preferably within In Vitro diagnostics: Conducting audits, knowledge in CAPA, Management Review and product vigilance processesFluent German and English are preferred.

For more information on this vacancy, or any other QA type medical device opportunities, please contact the Senior Consultant Andrew Boroky on 0044 (0) 207 940 2116, or email him at a.boroky@nonstop-devices.com